Medical Implantable Occlusion Device, And Method For Implantation Thereof

ABSTRACT

A medical implantable occlusion device is disclosed comprising a fabric of at least one thread and a structural formation thereof having a collapsed and an expanded shape, the formation comprises a proximal and a distal portion, a longitudinal axis extending between the proximal and distal portion, wherein at least one of the proximal and distal portions comprises a peripheral edge having a first and a second radius of curvature in a direction substantially perpendicular to the longitudinal axis, wherein the first radius of curvature is different from the second radius of curvature.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/241,062 filed Feb. 25, 2014 entitled Medical Implantable OcclusionDevice, And Method For Implantation Thereof, which is the U.S. NationalPhase of and claims priority to International Patent Application No.PCT/EP2012/068760, International Filing Date Sep. 24, 2012, entitledMedical Implantable Occlusion Device, And Method For ImplantationThereof, which claims benefit of U.S. Provisional Application Ser. No.61/537,623, filed Sep. 22, 2011 entitled Medical Implantable OcclusionDevice, And Method For Implantation Thereof; and European ApplicationNo. 11182390.2, filed Sep. 22, 2011 entitled Medical ImplantableOcclusion Device; all of which are incorporated herein by reference intheir entireties.

FIELD OF THE INVENTION

This invention pertains in general to the field of medical implants.More particularly the invention relates to an intraluminally deliverableocclusion device for selective occlusion of a target site in a bodylumen, such as the body's circulatory system, and more particularly forocclusion of paravalvular leaks, and method for implantation of suchocclusion device.

BACKGROUND OF THE INVENTION

Various intravascular deliverable devices are used for treating specificconditions via access through body lumina, such as patient's circulatorysystem. The target site may for instance be an atrial or ventricularseptum having a defective opening to be occluded, such as devices fortreating septal defects and the like. In certain circumstances, it maybe necessary to occlude a patient's lumen, vessel, chamber, channel,hole, or cavity such as to stop blood flow there through. One suchcondition known in the art is Para-Valvular Leak (PVL) which may occurin association with surgical implantation of prosthetic valves in theheart, and with interventional valve implantations in general, i.e.transcatheter aortic valve intervention (TAVI). When the prostheticvalve is fixed by sutures micro-holes are created where the suturespenetrate the tissue. These micro-holes can become dilated over time andgrow larger and also merge together, thereby creating undesired bloodpassages around the valve compromising the normal flow of blood throughthe valve. Any surgical procedure around the valve may create suchundesired leaks. Whether it is implantation of a prosthetic valve orprocedures around the native heart valve, sutures or other means thatmust penetrate the surrounding tissue may be the source of such leaks.Leaks around the valve may also arise because of other undesiredconditions. For example, after the replacement of the valve the pressureincreases which could cause damages on the degenerated tissue around thevalve area, such that leaks occur. That tissue can also be perforatedwith guide wires or guiding catheters during any other heart surgeryprocedure, with leaks as a consequence.

In the case of prosthetic valves, over 210.000 valve replacements areperformed each year world wide. In between 3-12% of the operations thereis paravalvular leakage, and 3-4% is critical and needs reoperation. Thediagnosis of paravalvular leak is done during the first year of theimplantation. The patient may have a small PVL that may not effect theblood transfusion but can be diagnosed with imaging techniques such asTEE. Usually surgical therapy is the standard for treating paravalvularleaks but reoperation increases mortality and morbidity as compared tothe first operation, i.e. reoperation is more difficult and increasesthe risk factor. After surgical reoperations 20% of the patients hasresidual or recurrent paravalvular leak. Another possibility is to usemedical therapy, which is palative, i.e. the symptoms can be decreasedbut hemodynamic anomalies can not be regulated.

Occlusion devices exist that are used for treating PVL. FIGS. 1a-b showssuch occlusion device when positioned at the periphery of the prostheticvalve from an atrial view (FIG. 1a ) and from a ventricular view (FIG.1b ). The occlusion device has portions positioned on either side of thevalve.

A problem with such previous occlusion devices is the disruption of theblood flow they create. Disruption of the blood flow is increasing risksfor the patient for other complications and is detrimental to patientsafety. The disruption can cause turbulence in the blood flow, whichcould increase the risks of embolies.

A further problem is the insufficient sealing that previous occlusiondevices provide. Insufficient sealing may lead to further reoperationsand unnecessary complications for the patient.

Another problem with the previous occlusion devices is the inability toadapt to the irregular and varying anatomy of the implantation site.Conformation to varying anatomies is critical for secure deployment ofthe occlusion device, without having to risk dislodgement and/orinsufficient sealing.

A further problem with previous devices is problems with orientation anddelivery of the device. Proper orientation is important for achievingthe correct function of the device, and also for ease of the procedure.

All aforementioned problems affect not only patient safety but alsoavailable resources in the health care system as each patient will takelonger to treat. Patient risks of previous paravalvular leak closuredevices and methods include embolization of the device, stroke,arythmia, perforation of the biological prosthetic valve, anddysfunction of the valve prosthesis.

WO2008153872 discloses a device to be positioned on either side of thewall of a tubular blood vessel. Arcuate portions of the device conformto the tubular blood vessels surface.

Hence, an improved implant would be advantageous and in particularallowing for increased patient safety, flexibility, and/orcost-effectiveness would be advantageous.

SUMMARY OF THE INVENTION

Accordingly, embodiments of the present invention preferably seeks tomitigate, alleviate or eliminate one or more deficiencies, disadvantagesor issues in the art, such as the above-identified, singly or in anycombination by providing a device and a method according to the appendedpatent claims.

Embodiments of the present invention may be well suited for theselective occlusion of a vessel, lumen, channel, hole, cavity, or thelike. One particular example, without limitation, of such a condition isPara-Valvular Leak (PVL). Another example is a vessel, lumen, channel,hole or shunt, through which blood flows from one vessel to anothervessel such as an Atrial Septal Defect (ASD) or a Ventricular SeptalDefect (herein after VSD), or Patent Ductus Arteriosus (PDA). Otherexamples could be an Arterial Venous Fistula (AVF), Arterial VenousMalformation (AVM), a Patent Foramen Ovale (PFO).

According to a first aspect of the invention a medical implantableocclusion device is provided comprising

a fabric of at least one thread and a structural formation thereofhaving a collapsed and an expanded shape. The formation comprises aproximal and a distal portion, a longitudinal axis extending between theproximal and distal portion, and at least one of the proximal and distalportions comprises a peripheral edge having a first and a second radiusof curvature in a direction substantially perpendicular to thelongitudinal axis, and the first radius of curvature is different fromthe second radius of curvature.

According to a second aspect of the invention a medical method ofoccluding an opening such as a PVL is provided, comprising providing adevice according to the first aspect of the invention, inserting thedevice in a collapsed state into the opening, expanding and releasingthe device in the opening, thus anchoring the device in the opening foroccluding the latter by the device.

Further embodiments of the invention are defined in the dependentclaims, wherein features for the second and subsequent aspects of theinvention are as for the first aspect mutatis mutandis.

Some embodiments of the invention provide for unrestricted blood flowthrough a prosthetic or native heart valve.

Some embodiments of the invention provide for flexible positioning of amedical implant to varying anatomical sites in a body of a human oranimal.

Some embodiments of the invention also provide for secure attachment ofa medical implant in a patient's vascular system.

Some embodiments of the invention provide for a medical implant that canbe safely delivered and oriented at treatment site in a patient.

It should be emphasized that the term “comprises/comprising” when usedin this specification is taken to specify the presence of statedfeatures, integers, steps or components but does not preclude thepresence or addition of one or more other features, integers, steps,components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIGS. 1a-b shows a medical implantable occlusion device according toprior art;

FIG. 2 is an illustration of a medical implantable occlusion deviceaccording to an embodiment of the invention;

FIGS. 3a-c are side views along cross-section a (CS) of the medicalimplantable occlusion device in FIG. 2;

FIG. 4 is an illustration of a medical implantable occlusion deviceaccording to an embodiment of the invention;

FIGS. 5a-c are illustrations of a medical implantable occlusion deviceaccording to an embodiment of the invention;

FIG. 6 is an illustration of a medical implantable occlusion deviceaccording to an embodiment of the invention when implanted at atreatment site;

FIGS. 7a-d are illustrations of a medical implantable occlusion deviceaccording to an embodiment of the invention;

FIG. 8 is an illustration of a medical implantable occlusion deviceaccording to an embodiment of the invention;

FIG. 9 is a flow chart illustrating a method of occluding a PVL in abody lumen with a medical implantable occlusion device according to anembodiment of the invention; and

FIGS. 10a-c are illustrations of a medical implantable occlusion deviceaccording to an embodiment of the invention, shown in top-down view (a),and side views (b)-(c), respectively.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

The following description focuses on an embodiment of the presentinvention applicable to a Para-Valvular Leak device (PLD). However, itwill be appreciated that the invention is not limited to thisapplication but may be applied to any other purposes of cardiac orvascular occlusion, and many other medical implantable devices,including for example filters, stents, Left Atrial Appendage (LAA)occluders, aneurysm treatment devices, grafts, etc.

FIG. 1 shows a medical implantable occlusion device 100 according to anembodiment of the invention. FIG. 4 shows a device 200 in anotherembodiment of the invention, which is similar to the device 100 in FIG.1 but with other relative dimensions. The device 100, 200, comprises afabric, mesh or braiding of at least one thread 101. The fabric may beformed from one thread or several. FIGS. 3a-c are cross-sections of thedevice 100, 200, along the line CS in FIG. 1 or FIG. 4, which will bediscussed in further detail below.

The device 100, 200, or more particularly the structural formation 102of the fabric of threads 101, has an unloaded expanded shape and acollapsed shape. Thus, in the expanded shape, wherein the device 100 hasa shape as depicted in FIG. 1 and FIG. 2, no external force acts on thedevice 100, 200. The device 100, 200, may be stretched and therebyexhibit a smaller cross-section, in order to fit inside a deliverydevice such as a catheter. The device 100, 200, may be self-expandablebetween the collapsed shape and the expanded shape, i.e. when the device100, 200, is removed from the confinement of the catheter thecross-section of the device 100, 200, returns to its originally definedvalue in the unloaded expanded shape. The device may be self-expandabledue to an inherent elasticity of the threads in the fabric or braiding.The device may also have a shape memory, e.g. triggerable to go to theexpanded shape at a switching temperature, such as body temperature.

The shape of the device 100, 200, in the expanded shape may be definedin a heat treatment procedure of the device 100, 200, or moreparticularly of the braiding of the device. The dimensions of the device100, 200, in the expanded, relaxed, shape are defined in the heattreatment procedure of the braiding.

The entire device 100, 200, may be comprised of a single, continuousfabric or braiding. The braiding may be made of a material suitable forimplanting in a human or animal body, and suitable for being formed in aheat treatment procedure to a desired shape in the expanded shape andalso in the stretched state. For example NiTinol may be used as amaterial for the device 100, 200. However, suitable materials forembodiments of the braiding are various and include shape memorymaterials, metal, superelastic alloys (such as NiTinol), or polymers,such as degradable polymers.

The structural formation 102 of the device 100, 200, comprises aproximal portion 103, and a distal portion 104. A longitudinal axis 105extends between the proximal and the distal portion, which is bestillustrated in FIG. 3a . In FIG. 3a it is also seen that the proximal,and distal portions 103, 104, may comprise expanded diameter portions103, 104, that are separated by a waist 106 of reduced cross-sectionbetween the proximal and distal portions 103, 104. The length 120 of thewaist 106 may correspond substantially to the wall thickness of thedefect to be occluded, when the proximal and distal portions 103, 104,are positioned on either side of such defect. The flexible nature of theat least one thread 101 of the device 100, 200, however allows thedevice to adapt to a wide range defect dimensions. The proximal anddistal portions 103, 104, will strive in a direction towards each otherto the expanded shape when separated by the defect, thereby closingagainst the walls on either side of the defect and providing theoccluding effect. The width 121 of the waist 106 may approximate thewidth of the defect, i.e. the width of the opening of the paravalvularleak defect.

FIGS. 10b and 10c show two different types of waists 106, along thecross-section A of the device 100 seen in a top-down view in FIG. 10a .According to one embodiment the waist may comprise narrowly or tightlytwisted threads 101, of the fabric or braiding of the device 100, aroundthe longitudinal axis 105, in order to produce a waist 106 of smallcross-section relative to the diameter of the proximal and distalportions 103, 104. This small cross-section allows for fitting of thedevice in small openings to be occluded. During manufacturing of thedevice 100, the proximal and distal portions 103, 104, may be twisted inrelation to each other around the longitudinal axis 105, during a heatsetting step, to produce a waist 106 with twisted threads 101. This maybe part of a subsequent heat setting step, after a first heat settingstep for forming the expanded diameter portions, i.e. the proximal anddistal portions 103, 104, and the reduced diameter portion, i.e. thewaist. Alternatively, the twisting is made during the same first heatsetting step.

The waist 106 may be made of a portion of parallel threads or a moredensely braided section of the fabric at the waist 106, providing forparticular strength in the longitudinal direction. The waist 106 may bearranged concentrically with respect to the proximal and distal portions103, 104, but an asymmetric configuration may be suitable in particularanatomies to be occluded.

At least one of the proximal and distal portions 103, 104, comprises aperipheral edge 107, 108, having a first 109, 109′, and a second 110,110′, radius of curvature in a direction substantially perpendicular tothe longitudinal axis 105. The first radius of curvature 109, 109′, isdifferent from the second radius of curvature 110, 110′. In this way theperipheral edge 107, 108, may conform to various anatomical geometriesneighboring the defect to be occluded, hence avoiding unnecessaryblockage and disruption of e.g. blood flow, while still providing theocclusion of the defect.

In case of paravalvular leak defects (PVL) the at least one of the firstand second radius of curvatures may be chosen such that the curvature ofat least a section of the peripheral edge 107, 108, correspondssubstantially to a valve curvature 116 of a valve 115 for regulatingblood flow. This is illustrated in FIG. 6, where the device 200 occludesa PVL close to the outer boundary of the valve 116. The device 200 has aperipheral edge 108 with a second radius of curvature 110′ thatcorresponds substantially to the valve curvature 115. The first radiusof curvature 109′ as exemplified in FIG. 6 is different from the secondradius of curvature 110′ of the peripheral edge 108, and the peripheraledge 108 may have any shape to conform to varying neighboring geometrieswhere the influence of the occlusion device must be minimized whileproviding the necessary occlusion effect.

A prior art device 10 is shown in FIGS. 1a-b , which is a typicalexample of the influence such prior art devices have on the prostheticvalve because of its substantial blockage of the valve 115 whenpositioned in a PVL at the periphery of the valve 20. FIG. 1a is a viewfrom the atrial side, and FIG. 1b is a view from the ventricular side,where the latter most clearly shows the device 10 extending over asubstantial portion of the valve 20. Such device 10 may disrupt theblood flow, create turbulence and lead to various complications asdiscussed above. Returning to FIG. 6, the corresponding overreach acrossthe valve 115 resulting from such prior art devices is marked withdashed line 121. The varying radius of curvature 109′, 110′, of thedevice 100, 200, allows occlusion of PVL close to the valve 115 withoutany overreach across the valve and the associated complications. FIGS.5a-c illustrates the amount of area that is saved by the device 100,200, which otherwise would have negative impact. FIG. 5a shows thecoverage by a prior art device 10 (dashed lines), and FIG. 5b shows thecoverage by the device 200, while FIG. 5c shows the differential area122 that is saved which will not block the flow of blood through thevalve 115.

Both the proximal and distal portions 103, 104, may have peripheraledges 107, 108, with varying radius of curvature. FIG. 2 shows the firstand second radius of curvature 109, 110, for the proximal portion 103,and the first and second radius of curvature 109′, 110′, of the distalportion 104 for the device 100. FIGS. 4 and 6 shows a similarconfiguration for the device 200. In this way the blood flow will not bedisrupted on any side of the valve 115.

The dimensions of the device 100, 200, such as indicated in FIGS. 2 and3, c.f. A, A′, B, B′, C, C′, C″, C′″, D, E, may be adapted such thatproper alignment of the device 100, 200, to the valve curvature 116 isachieved.

As seen in FIGS. 2, 4, 5, 6, the peripheral edge 107, 108, is concaveradially outwards. I.e. in a direction substantially perpendicular tothe longitudinal axis 105, FIG. 3a . This allows the peripheral edge107, 108, to follow the convex shape of the valve curvature 116, so thatno overlapping of the valve 115 occurs. The radius of curvature of theconcave part can be varied as desired in order to achieve the closestcorrespondence with the valve curvature 116. The number of concavesections of the peripheral edge 107, 108, may vary. The devices 100,200, in FIGS. 2, 4, 5, 6, have four concave sections, but it could beone, two, three, five or more. Leaks can occur around the valve 115 at a360 deg location. The curvature of the peripheral edge 107, 108, may besized and shaped to cover several PVL's around the valve curvature 116.Due to the varying radius of curvature or the concave peripheral edge107, 108, several PVL's may be occluded with a single device 100, 200,without extending across the valve 115 and disturbing the blood flow.

As further shown, e.g. in FIG. 2, the peripheral edge 107, 108,comprises edge sections 112, 112′, 113, 113′, that are alternatinglyconcave and convex radially outwards in a direction substantiallyperpendicular to the longitudinal axis 105. Each of the concave edgesections 112, 112′, also seen in FIG. 4 and denoted 114, 114′, may bepositioned against the valve curvature 116. The devices 100, 200, havethe convex sections 113, 113′, positioned in between the concavesections 112, 112′, which results from having a several concavesections.

The geometric terms concave and convex as used herein is to beinterpreted for the purposes of the invention as their normalgeometrical meaning including any recesses in the device for the purposeof the term concave and protrusions of the device for the purposes ofthe term convex, where such recesses and protrusions may also define thespatial extent of the device 100, 200, i.e. the peripheral edge 107,108, such that the device 100, 200, may follow the valve curvature 116.The peripheral edge 107, 108, may be continuous without sharpinterruptions, kinks or corners, as illustrated in the Figures, orcomprise discontinuous sections.

The device 100, 200, has radially opposed edge sections 112, 112′, 114,114′, of the peripheral edge 107, 108, that have substantially the sameradius of curvature, e.g. as seen in FIGS. 2 and 4. Such symmetry mayprovide ease of positioning against the valve curvature 116. In FIG. 2,the device 100, has substantially the same radius of curvature for allconcave sections of the peripheral edge 107, 108. Alternatively, thedevice 100, 200, may comprise concave edge sections having differentradius of curvatures 109, 109′, 110, 110′, which allows the device 100,200, to conform to a wide range of valves 115, having different valvecurvatures 116.

FIG. 4 shows a device 200 having first radially opposed edge sections112, 112′, of the peripheral edge 107, 108, having a radius of curvaturethat is larger than the radius of curvature of second radially opposededge sections 114, 114′. As mentioned above this may provide selectivityto various geometries of the valve 115. By simply rotating the device200, the physician may select one peripheral edge with a particularradius of curvature that conforms best to the valve curvature 116,and/or the opening to be occluded. Also, the device 200 may provideincreased holding strength against the defect to be occluded by itsincreased radial extent along a first axis, while maintaining thelimited radial extent along a second axis, being perpendicular to thefirst axis, i.e. the second axis extending in direction across the valve115. Overlap across the valve 115 by the device 200 (along theaforementioned second axis) is thereby avoided, while increased holdingstrength is provided.

The peripheral edge may comprise at least two edge sections 112, 112′,or 114, 114′, that are concave radially outwards in a directionsubstantially perpendicular to said longitudinal axis. Having more thanone concave edge may allow selectivity as described above, and/or easeof positioning if the edges have similar radius of curvature.

Further, by having a rotational symmetric device 100, 200, around axis105, the ease of handling and insertion, and also stability andstructural integrity of the device can be increased. This can berealized by having two radially opposed concave edges as describedabove. The radius of curvature of the peripheral edge 107, 108, maycorrespond to a particular defect to be occluded and/or the curvature ofthe valve.

The device 100, 200, may have a peripheral edge 107, 108, that defines agenerally rectangular shape of the proximal or distal portion 103, 104.As seen in FIGS. 2 and 4, the device 100, 200, has four convex corners,see e.g. edge sections 113, 113′, and concave sections in between, 112,112′. The peripheral edge 107, 108, may have a radius of curvature thatvary considerably, e.g. the convex corners 113, 113′, of the device 100,200, may be in the form of a sharp transition from one concave edgesection to the next, as alternative to a smooth continuous transition.In either case the device 100, 200, may be referred to as having agenerally rectangular shape due to having four corners in the Figs. Asmentioned above the number of concave sections 112, 112′, and corners,i.e. convex sections 113, 113′ may vary, and the device 100, 200, mayhave generally triangular, pentagonal shapes etc, as long as theperipheral edge 107, 108, has at least a section of its curvature thatcan be positioned close to the valve curvature 116 without extendingacross the valve 115, when the device 100, 200, is in its implantedsite.

At least one of the proximal and distal portions 103, 104, may bedeflected towards the other portion with an angle V, V′. In this way thedevice 100, 200, may better accommodate to the anatomy at the implantedsite and thereby provide a closer fit against the tissue by the proximaland/or distal portion 103, 104, for improved occlusion. For example, atthe periphery of the valve 115, there is often a “volcano crest”, i.e. aprotrusion going around the periphery. When the proximal or distalportion 103, 104, is positioned close to that protrusion the deflectionof the aforementioned portions towards each other with angle, V, V′,allows these portions to reach over the protrusion and down to thetissue nest to the protrusion for a secure fit. FIG. 3a shows thecross-section of the device 100, 200, where the proximal portion 103 isdeflected towards the distal portion 104 with an angle V, and the distalportion 104 is deflected towards the proximal portion 103 with an angleV′. The angles V and V′ may be substantially the same or differentdepending on the anatomy of the site in the vascular system to beoccluded. E.g. the distances 123, 124, as indicated in FIG. 3a , may bevaried. Only one of the portions 103, 104, may be angled towards theother. The device 100, 200, may thereby be adapted to the irregular andvarying anatomy of the implantation site. This also allows for aparticular stable long-term construction even in anatomical situationswhere a continuous movement at the implantation site is present.

One of the proximal and distal portions 103, 104, may have a largerdiameter than the other portion, thereby creating an overlap 117 betweenthe proximal and distal portions 103, 104. The overlap may provideincreased sealing ability of the device 100, 200, e.g. when the portions103, 104, being pressed towards each other. The overlap maysubstantially be in the radial direction, perpendicular to longitudinalaxis 105. As seen in FIG. 3a , the distal portion 104 overlaps theproximal portion 103 in the radial direction, which is also seen in e.g.FIG. 2 with respect to peripheral edges 107, 108. When the distalportion 104 is placed on the side of the defect being exposed to highpressure, e.g. on the ventricular side of the heart (depending on whichvalve that has PVL; Aortic, Mitral, Tricuspid, or Pulmonary), the largerarea of the distal portion 104 will improve the sealing against thetissue, while the smaller area of the proximal portion minimizes overlapacross the valve 115. Thus a secure occlusion is achieved even beforethe device 100, 200, is securely covered with endothelia and tissueintegrated with the surrounding tissue.

The diameter may be equivalent to the largest cross-section throughoutthe disclosure.

The proximal and distal portions 103, 104, may be substantially flat andhaving a diameter larger than the opening of the PVL which it is placed.

FIGS. 7a-d shows perspective view of the device 100, 200, i.e. FIG. 7ais a tilted side view, FIG. 7b is a side view, FIG. 7c is a top-downview facing the proximal portion 103, and FIG. 7d is a top-down viewfacing the distal portion 104. Even though the device in FIGS. 7a-d moreclosely reassembles the device 100 in FIG. 2 due to having substantiallysides of equal length, the perspective views in the Figs. is alsorepresentative of the device 200 in FIG. 4. The device 100, 200, maycomprise at least one a marker element 118, 118′, for aiding inorienting the device 100, 200. Such marker 118, 118′, allowsidentification of the device and reassurance that the device has beenimplanted correctly. For example, it can be determined whether theconcave edge section 112 of the peripheral edge 107, 108, has beenaligned against the valve curvature 116. Thus, the at least one markerelement 118, 118′, may be arranged on one of the proximal and distalportions 103, 104, at a position corresponding substantially to thelocation of the peripheral edge 107, 108. FIG. 8 illustrates thelocation of two markers 118, 118′, which are close to the peripheraledge 107 of the proximal portion 103. The markers 118, 118′, may bearranged on opposite concave sections, as illustrated in the figure forallowing correct positioning. The markers 118, 118′, may be attached tothe proximal portion 103, or to the distal portion 104. Hence, themarkers 118, 118′, in FIG. 8 could be attached to the distal portion104, for marking out the position of the peripheral edge 107 of theproximal portion 103. As the distal portion 104 may have increaseddiameter or circumference, the markers 118, 118′, could be attached tothe distal portion 104 at a distance from the peripheral edge 108 of thedistal portion 104, while still marking out the peripheral edge 107 ofthe proximal portion. This may allow for easier attachment of themarkers 118, 118′, to the device 100, 200, and less interference withthe operation of the device 100, 200, as the markers do not have to beattached to the proximal peripheral edge 107, while still allowing exactpositioning with respect to the valve curvature 116 with the proximalperipheral edge 107.

The marker element 118 may comprise a radiopaque material, hence beingidentifiable in X-ray, or comprise material for easy identification inMRI. The device 100, 200, may comprise two markers 118 as shown in FIG.7d , arranged across the radial direction of the distal portion 104,and/or alternatively of the proximal portion 103. Any number of markers118 may be used for identification. The markers 118 may be fixated to anoccluding element such as a patch, fibers or the like comprising abiocompatible material (e.g. PET) for supporting the sealing of theblood flow through the device 100, 200, or fixed to the fabric ofthreads 101 of the device 100, 200, itself.

As shown in FIGS. 3b, 3c and FIGS. 7a-c , the device 100, 200, maycomprise a connecting member 111 attached to one of the distal andproximal portions 103, 104, for connection to a delivery device (notshown). The delivery device may grasp the connection member 111 whichmay be spherical in shape, thus providing a pivoting motion of thedevice 100, 200, in relation to the delivery device in combination withsecure attachment. The connection member 111 may be arranged on theproximal portion 103 as shown in FIG. 3b , or on the distal portion 104as shown in FIG. 3c . FIG. 7a-c illustrates the device 100, 200, havingthe connection member 111 on the proximal portion 103. In reality theportion having the connection member 111 becomes the proximal portion inuse of the device, but the above conventions are used for conciseness inthe description and figures. Hence, the connection member 111 may bearranged on the expanded diameter portion 104, or the increased diameterportion 104. This allows the possibility to access the PVL from bothsides of the leak.

The connecting member 111 may be configured for connection to a deliverydevice in a predetermined orientation. Hence a specific orientation ofthe device 100, 200, could be maintained relative to the delivery deviceduring implantation which may aid in positioning the device 100, 200, inrelation to the valve curvature 116.

The ends of the at least one thread 101 forming the fabric may be fixedto the connecting member 111. The connecting member 111 may thus be aweld or any other attachment means for the threads 101 of the fabric.The distal portion 104 may comprise returning loops 119 of the at leastone thread 101, meaning that opposite ends of the at least one thread101 forming the distal portion 104 are fixed to the connecting member111. By having returning loops only one collection point for the ends ofthe at least one thread 101 is needed. The connection member 111 maythus serve as a connection for these ends, thereby avoiding multipleconnection points such as welds on the distal portion 104. Hence, a flatdistal portion 104 may be provided, that increases the compactness ofthe device 100, 200. The flat distal portion 104 may thus be a closedcontinuous distal wall 301 of the braiding forming the device 100, 200,i.e. free from a thread ends. This reduces the risk thromboemboliccomplications. E.g. nothing is protruding into the blood stream, andthere are no discontinuities that may cause thromboemboliccomplications. Further, due to the connection member 111 on the proximalend 103, the device 100, 200, may be delivered through the vena cavawith improved safety to the patient. The implantation techniques aredifferent for each PVL according to the valve and the location of theleak. Delivery to the high pressure arterial side of the vascular systemis avoided, which provides for less complications and a medicalprocedure which is simpler to perform.

FIG. 9 illustrates a medical method 900 of occluding an opening in abody lumen, comprising providing 901 a device 100, 200, inserting 902the device 100, 200 in a collapsed state into the opening, expanding 903and releasing the device 100, 200, in the opening, thus anchoring 904the device 100, 200, in the opening for occluding the latter by thedevice 100, 200. The opening may be a Para-Valvular Leak (PVL), and themethod may comprise positioning 905, or rotating, the device 100, 200,such that a concave edge section 112, 112′ of the device 100, 200,substantially follows the valve curvature 116 of the valve 115.

The present invention has been described above with reference tospecific embodiments. However, other embodiments than the abovedescribed are equally possible within the scope of the invention. Thedifferent features and steps of the invention may be combined in othercombinations than those described. The scope of the invention is onlylimited by the appended patent claims.

More generally, those skilled in the art will readily appreciate thatall parameters, dimensions, materials, and configurations describedherein are meant to be exemplary and that the actual parameters,dimensions, materials, and/or configurations will depend upon thespecific application or applications for which the teachings of thepresent invention is/are used.

1. A medical method of occluding an opening in a body lumen, the openingbeing a Para-Valvular Leak (PVL) adjacent a valve, the method comprisingproviding a medical implantable occlusion device comprising a braidingof at least one thread forming a structural formation having a collapsedand an expanded shape, said formation comprises a proximal and a distalportion, a longitudinal axis extending between said proximal and distalportion, wherein at least one of said proximal and distal portioncomprises a peripheral edge having a first and a second edge section,wherein at least one of the first edge section and the second edgesection is inwardly curved relative the longitudinal axis, the methodfurther comprising inserting said device in said collapsed state intosaid opening, positioning or rotating said device such that the inwardlycurved edge section substantially follows a valve curvature of saidvalve when said device is expanded, expanding said device to saidexpanded shape in said opening.
 2. The method of claim 1, positioningthe occlusion device so that the distal and proximal portions are onrespective sides of the opening, and positioning a waist of reducedcross section between said distal and proximal portions of said devicein said opening.
 3. The method of claim 1, wherein the device comprisesmore than one inwardly curved edge sections, and wherein saidpositioning or rotating the device comprises rotating the device toconform to a curvature of the opening.
 4. The method of claim 1, whereinsaid second edge section is curved inwards in a direction substantiallyperpendicular to said longitudinal axis wherein said occlusion device isrotational symmetric around said longitudinal axis, and furthercomprising positioning or rotating said device to follow a outwardlycurved shape of said curvature of said valve.
 5. The method of claim 1,comprising positioning a flat distal portion of said formation such thatit does not substantially protrude into a blood stream.
 6. The method ofclaim 5, wherein said flat distal portion is a closed continuous distalwall free from thread ends.
 7. The method of claim 1, wherein at leastone of the proximal and distal portions comprises at least one markerelement, and further comprises orienting said marker relative saidopening.
 8. The method of claim 1, comprising grasping a connectingmember of the device with a delivery device, positioning or rotatingsaid device and releasing said delivery device from said connectingmember after expanding said device to said expanded shape in saidopening.
 9. The method of claim 1, further comprising delivering theocclusion device to said opening via vena cava.
 10. The method of claim1, comprising rotating or positioning said device such that the inwardlycurved edge section is directed tangentially along the valve curvature.11. The method of claim 1, wherein said second edge section is curvedoutwardly relative said longitudinal axis, further comprising rotatingor positioning said device such that the outwardly curved edge sectionis directed tangentially away from the valve curvature.
 12. The methodof claim 1, comprising rotating or positioning said device such that theinwardly curved edge section is directed tangentially along the valvecurvature, and wherein said second edge section is curved outwardlyrelative said longitudinal axis, further comprising rotating orpositioning said device such that the outwardly curved edge section isdirected tangentially away from the valve curvature.